NCT04397796Unknown1 期
Phase 1b Randomized, Double-Blind, Placebo-Controlled Study Of The Safety Of Therapeutic Treatment With Immunomodulatory Mesenchymal Stem Cells In Adults With COVID-19 Infection Requiring Mechanical Ventilation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events Within 30 Days of Randomization
研究概览
简要总结
This is a phase 1b randomized, double-blind, placebo-controlled study in adult subjects with Coronavirus Disease 2019 (COVID-19). This clinical trial will evaluate the preliminary safety and efficacy of BM-Allo.MSC vs placebo in treating subjects with severe disease requiring ventilator support during COVID 19 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. For subjects that are intubated and/or sedated, or otherwise unable to provide consent, prospective consent from a legally-authorized representative is required. The subject or his/her legally authorized representative must be able to provide consent.
- •Has laboratory-confirmed positive novel coronavirus (SARS-CoV-2) test, as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to enrollment, or meets the criteria to guide the evaluation and testing of patients under investigation (PUI) for COVID-19 (https://emergency.cdc.gov/han/2020/HAN00428.asp).
- •Requiring mechanical ventilatory support with moderate to severe Acute Respiratory Distress Syndrome (ARDS) as determined by the Berlin criteria:
- •Bilateral opacities present on a chest radiograph or computed tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
- •Origin of Edema: Respiratory failure not fully explained by cardiac failure or fluid overload.
- •Oxygenation: Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:
- •Moderate: PaO2/FiO2 >100 mmHg and ≤ 200 mmHg, on ventilator settings that include PEEP ≥ 5 cm H2O
- •Severe: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm H2O Subjects receiving extracorporeal membrane oxygenation (ECMO) will not be enrolled in this study.
- •High-sensitivity C-reactive Protein (hs-CRP) serum level > 4.0 mg/dL
- •Acute Physiology and Chronic Health Evaluation (APACHE IV) score > 5
- •Agrees to the collection of nasopharyngeal (NP) swabs and venous blood per protocol.
- •Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- •Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 1 month after the last dose of BM-Allo.MSC. Non-sterile male subjects must agree to use a condom while on study and for up to 1 month after the dose of BM-Allo.MSC. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.
排除标准
- •Known hypersensitivity to any component of the study medication(s).
- •Signs of multisystem organ failure. Liver function tests (LFTs) > 5x normal.
- •Intubated > 72 continuous hours.
- •Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- •Pregnant and nursing women. A negative serum pregnancy test during screening (within 72 hours prior to the first dose) must be documented before MSCs are administered to a female subject of child-bearing potential.
研究组 & 干预措施
BM-Allo.MSC
Experimental
Subjects in the experimental arm will be administered BM-Allo.MSC
干预措施: BM-Allo.MSC (Biological)
Placebo
Placebo Comparator
Subjects in the control arm will be treated with placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Participants With Adverse Events Within 30 Days of Randomization
时间窗: 30 days
Incidence of AEs within 30 days of randomization.
次要结局
未报告次要终点
研究者
研究点 (1)
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